Chest Rub Jelly
FDA Label NDC 68016-248

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pharmacy Value Alliance, Llc for the product Chest Rub (NDC 68016-248). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding additional warnings, active ingredients, purpose, use, warnings, do not use, ask a doctor before use if you have, when using this product, do not, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Additional Warnings

Failure to follow these warnings could result in serious consequences  

Active Ingredients

Camphor 4.8%

Eucalyptus oil 1.2%

Menthol 2.6%

Purpose

Cough suppressant + topical analgesic
Cough suppressant
Cough suppressant + topical analgesic

Use

•on chest and throat, temporarily relieves cough due to the common cold
•on muscles and joints, temporarily relieves minor aches and pains

Warnings

For external use only; avoid contact with eyes.

Do Not Use

•by mouth

•with tight bandages

•in nostrils

•on wounds or damaged skin

Ask A Doctor Before Use If You Have

  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smokng, asthma or emphysema

When Using This Product, Do Not

  • heat
  • microwave
  • add to hot water or any container where heating water.
    May cause splattering and result in burns.

Stop Use And Ask A Doctor If

  • muscle aches and pains persist more than 7 days or come back
  • cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache.
    This could be signs of a serious condition

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Directions

See important warnings under "When using this product"
•adults & children 2 yrs & over:

•rub a thick layer on chest & throat or rub on sore aching muscles

•cover with a warm, dry cloth if desired

•keep clothing loose about throat/chest to help vapors reach the nose/mouth

•repeat up to three times per 24 hours or as directed by doctor

•children under 2 years of age: ask a doctor

Other Information

•store at room temperature

Inactive Ingredients

cedarleaf oil, nutmeg oil, special petrolatum, spirits of turpentine, thymol

Questions

Call 1-888-593-0593

Side Panel Information

Medicated

Chest Rub

Cough Suppressant/ Topical Analgesic

The active ingredents in Premier Value Medicated chest rub work naturally by breathing in the medicated vapors to relieve coughing due to colds.

Premier Value Medicated Chest Rub also relieves minor aches and pains

Other

This product is not manufactured or distributed by Procter & Gamble, distributor of Vicks VapoRub

Adverse Reactions

Distributed By:

Pharmacy Value Alliance, LLC

407 East lancaster Avenue,

Wayne, PA 19087

www.emersongroup.com

Principal Display Panel

Compare to

Vicks Vapor Rub

Premier

Value

Medicated

Chest Rub

Cough Suppressant/Topical Analgesid

NET WT

3.53 OZ (100 g)

Image Description (Mm3)

Image Description (Mm3)

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